Senior Manager, Commissioning Engineering

Bristol Myers Squibb; Massachusetts; On-site; USD 135,000 - 163,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Sr. Manager, Commissioning Engineering to lead commissioning activities at the Devens, MA site within Validation Engineering.

The role oversees project onboarding, vendor management, and qualification execution for capital projects, collaborating across Engineering, Digital Plant, Facilities, and Quality. Candidates should have 6+ years in FDA-regulated environments; BS in Chemical or Mechanical Engineering; Masters preferred.

Qualifications

• 6+ years of experience with process equipment and automation in FDA-regulated manufacturing.
• Experience with commissioning and qualification of equipment/utilities.
• Excellent project management and technical writing skills.

Responsibilities

• Lead commissioning, installation, and PQ/IQ/OQ of project systems.
• Draft and oversee commissioning protocols and reports.
• Coordinate with vendors and project engineering to prep systems for installation.
• Manage multiple capital projects and report progress to site management.
• Collaborate with Engineering, Digital Plant, Manufacturing and Quality.
• Develop and lead a high-performance commissioning team.

Skills

Project management

GxP commissioning

Vendor management

Cross-functional leadership

Engineering documentation

Education

Chemical Engineering

Mechanical Engineering

Masters/Graduate degree preferred

Job description

PRINCIPAL OBJECTIVE OF THE POSITION:

The position, Sr. Manager Commissioning Engineering will be part of the Validation team reporting to the Associate Director, Validation Engineering and support clinical and commercial Devens manufacturing facility. This position may lead contractors for complete asset life cycle onboarding oversight of commissioning and any other effort arising from design and implementation of new/modified asset(s) as part of capital projects at the Devens site. The incumbent will apply existing and new knowledge of Engineering Project Management to support multiple, high-pace projects across multiple functions as part of the commissioning phase of asset introduction and/or modifications.

The position is responsible for organizing and completion of commissioning program documents and deliverable templates in accordance with BMS project practices and GMP qualification policies. Other responsibilities of this position include but are not limited to: contractor management, vendor qualification, scheduling of vendor qualification, factory acceptance testing, and assisting in asset onboarding to the site cMMS system and other duties as assigned.

MAJOR DUTIES AND RESONSI-BILITIES

1. Leads functions responsible for commissioning, vendor installation, operational and performance qualification (I/O/PQ) of systems arising from projects.
2. Draft / oversight of commissioning protocol, execute and write commissioning reports.
3. Work with vendors and project engineering to ensure systems are ready for installation, and start-up testing. Work with support department such as Digital Plant, Facilities, Metrology and Maintenance to ensure systems are installed adequately and ready for qualification (for GxP direct impact system) or released to system owners for system use (for non-GxP systems).
4. Manage multiple projects while serving as a point of contact for capital execution projects. Partner with project managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management.
5. Works collaboratively with Engineering, Digital Plant, Manufacturing and Quality.
6. Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
7. Ensure alignment with BMS directives and industry guidelines on commissioning.
8. Develops and leads a high-performance team responsible for commissioning execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.
9. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies.
10. Performs other duties as assigned by Commissioning Head.

KNOWLEDGE AND SKILL

• You should have the ability to execute smaller, but complex technical projects. You must have demonstrated effectiveness working in both a team environment as well as an individual contributor role.
• Direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.
• Previous managerial experience (is preferred) which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources preferred.
• A working understanding of lean principles is preferred. Excellent project management, communication, and technical writing skills are required.
• Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
• Demonstrated understanding of engineering documentation such as P and IDs, Process Flow diagrams and Standard Operating Procedures.
• Proven ability working in a matrix environment and leading multi-level / cross-functional teams to achieve the highest performance in meeting site and departmental objectives.

QUALIFICATIONS

• A minimum of 6+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.
• Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required. A Masters/Graduate degree in a technical discipline is preferred.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Devens - MA - US: $134,550 - $163,039

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607607 : Senior Manager, Commissioning Engineering